Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New epilepsy drug vormatrigine tested for Long-Term safety in 700 adults

NCT ID NCT07287163

Disease control Sponsor: Praxis Precision Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study is testing the long-term safety of a once-daily drug called vormatrigine in 700 adults with focal or generalized tonic-clonic seizures. Participants must have already taken vormatrigine in a previous trial or program. The main goal is to check for side effects and changes in vital signs, not to measure how well the drug stops seizures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vormatrigine (a once-daily oral drug for seizures)
What this could lead to
If successful, this could confirm that vormatrigine is safe for long-term use and help control seizures in adults with epilepsy.
What could go wrong
This is an extension study focused on safety, not on proving the drug works. It only includes people who already tolerated the drug, so results may not apply to all patients. Side effects are still being monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded access program) * Participant who had adequate seizure diary and vormatrigine adherence and had been otherwise adherent to the study procedures in the opinion of the investigator unless deemed unacceptable by sponsor Exclusion Criteria: * Participant who withdrew or discontinued treatment from the treatment period of an eligible clinical trial unless deemed acceptable by the sponsor * Participant who plans to enter another interventional investigational study or is on any prohibited medication * Participant who is pregnant, lactating or planning to become pregnant * Participant who is ineligible for the extension clinical trial in the view of the investigator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Epilepsy, tonic-clonic are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

epilepsy epilepsy with generalized tonic-clonic seizures focal epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy, tonic-clonic Focal seizure Primary generalized seizure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Praxis Research Site

    Miami, Florida, 33186, United States

  • Praxis Research Site

    Miami Lakes, Florida, 33016, United States

  • Praxis Research Site

    Naples, Florida, 34116, United States

  • Praxis Research Site

    Lafayette, Louisiana, 70508, United States

  • Praxis Research Site

    Bethesda, Maryland, 20817, United States

  • Praxis Research Site

    Plymouth, Michigan, 48170, United States

  • Praxis Research Site

    Chesterfield, Missouri, 63005, United States

  • Praxis Research Site

    Hackensack, New Jersey, 07601, United States

  • Praxis Research Site

    Amherst, New York, 14226, United States

  • Praxis Research Site

    Middletown, New York, 10941, United States

  • Praxis Research Site

    New York, New York, 10016, United States

  • Praxis Research Site

    Niagara Falls, New York, 14304, United States

  • Praxis Research Site

    Philadelphia, Pennsylvania, 19107, United States

  • Praxis Research Site

    El Paso, Texas, 79912, United States

  • Praxis Research Site

    Houston, Texas, 77058, United States

  • Praxis Research Site

    Porto Alegre, Rio Grande do Sul, Brazil

  • Praxis Research Site

    São José do Rio Preto, São Paulo, Brazil

  • Praxis Research Site

    Bielefeld, 33617, Germany

  • Praxis Research Site

    Tübingen, 72076, Germany

  • Praxis Research Site

    Pozzilli, Isernia, Italy

  • Praxis Research Site

    Bosisio Parini, Lecco, Italy

  • Praxis Research Site

    Milan, 20133, Italy

  • Praxis Research Site

    Naples, Italy

  • Praxis Research Site

    Pavia, 27100, Italy

  • Praxis Research Site

    Pisa, Italy

  • Praxis Research Site

    Ponderano, Italy

  • Praxis Research Site

    Roma, Italy

  • Praxis Research Site

    Bydgoszcz, 85163, Poland

  • Praxis Research Site

    Katowice, 40123, Poland

  • Praxis Research Site

    Lublin, Poland

  • Praxis Research Site

    Warsaw, Poland

  • Praxis Research Site

    Barcelona, 08003, Spain

  • Praxis Research Site

    Madrid, 28040, Spain

  • Praxis Research Site

    Málaga, 29010, Spain

  • Praxis Research Site

    Terrassa, 08222, Spain

  • Praxis Research Site

    Valencia, 46026, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.